Clinical Trial Manager

3 weeks ago

Swansea, United Kingdom yolk recruitment Full time €45,000

Clinical Trials Manager
£Hybrid working
Yolk Recruitment has a new opportunity for a Clinical Trials Manager to join an expanding manufacturer who are leading competitors within the Medical Sector.
This role reports directly to the Director of Clinical Affairs and is an opportunity for an established Clinical Trials Manager to join a secure company who offer professional growth and development.
Duties will include designing plus authoring trial documentation and regulatory submissions, plus monitoring the progress and performance of multiple trials from participant identification and recruitment through to ensuring reliable data collection. This will be achieved through implementing/modifying established department procedures to ensure studies are conducted in accordance with contractual agreements, protocol, SOPs, regulatory and ethical requirements including ICH-GCP guidelines. What you will be doing as Clinical Trials Manager:

Design clinical and application research studies.
Author Clinical Investigation Plans (CIP) and Final Study Reports (FSR)
Statistically analyse clinical data
Prepare abstracts, power-point presentations and posters for submission to scientific conferences.
Understand how clinical data can best assist product launch/sales.
Conduct audits and trend /gap analysis on key elements of trial execution.
Assume PI responsibility for all clinical trials.
Develop operational project plans.
The skills you will bring as Clinical Trials Manager:

BSc or equivalent in biomedical, health of life science field
Proven clinical trial experience, clinical trial management; Working knowledge of EU Clinical Trials Directive, Medical Device Directive, UK Clinical Trials Regulations, Principles of ICH-GCP, GDPR and Research Governance Framework Legislation with proven ability to apply these to the coordination of clinical trials.
Understanding of current EU Medical Device Regulation
Evidence of preparing regulatory and ethics submissions, writing/amending Clinical Investigation Plans, Patient Information Forms and electronic Case Report Forms, plus other relevant trial management documentation
If you feel you have the skills, experience and passion to be successful in this Clinical Trials Manager role apply now
*Please keep an eye on our website for more opportunities.

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